19 results
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38ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IM-5B MICROINJECTOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Premier Cavity Prep
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783008364·CALIF CUTTING INSTR 36/37
PERMITE
FDA UDI
SDI LIMITED·09336472000561·PERMITE 3SP REG 50
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780156949·Integra® Jarit® Valve Top Cap For #'s 600-330 &...
PERMITE
FDA UDI
SDI LIMITED·DO3640033032·
Alpha-Tec Systems
FDA UDI
Alpha-TEC Systems, Inc.·00816085021508·100% Ethanol
3M™ Unitek™ APC™ Clarity™ MBT™
FDA UDI
3M UNITEK CORPORATION·00652221236883·APC FF Clarity Ultra SL MBT U Lt Lateral 10T/8A...
HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS FOR THE LIMB
FDA 510(k)
FDA Class 2
·Cardiovascular
BREAST IMMOBILIZATION DEVICE MR-BY 160
FDA 510(k)
FDA Class 2
·Radiology
LVP PRIMARY ADMIN SET 2 INLET AND YSITE
FDA Adverse Event
Malfunction
·FRESENIUS KABI USA, LLC·Product code FPA·June 21, 2024
LVP PRIMARY ADMIN SET 2 INLET AND YSITE
FDA Adverse Event
Malfunction
·FRESENIUS KABI USA, LLC·Product code FPA·June 21, 2024
MESH - COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC.·Product code FTL·June 14, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·August 12, 2014
CELL-DYN SAPPHIRE ANALYZER
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·February 27, 2008
AUTOSOFT 90
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 16, 2024
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024